An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

January 31, 2022 updated by: Organon and Co

MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1375

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion Criteria:

  • Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
montelukast sodium 5 mg, QD 2-weeks
Drug: montelukast sodium
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
Other Names:
  • Singulair
  • MK0476
Experimental: 2
montelukast sodium 10 mg QD 2-weeks
Drug: montelukast sodium
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
Other Names:
  • Singulair
  • MK0476
Active Comparator: 3
Pranlukast 225 mg BID 2-weeks
Drug: Comparator: pranlukast
Pranlukast 225 mg BID 2-weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Composite Nasal Symptom Score

Secondary Outcome Measures

Outcome Measure
Daytime nasal symptom score, Nighttime nasal symptom score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 8, 2005

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-327
  • MK0476-327
  • 2005_038

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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